ZOTON FasTabs 30 mg
Country: Australia
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
lansoprazole
Available from:
Pfizer Australia Pty Ltd
INN (International Name):
lansoprazole
Dosage:
30 mg
Pharmaceutical form:
orally disintegrating tablets
Patient Information leaflet
ZOTON FASTABS
®
_Lansoprazole Tablets_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Zoton FasTabs. It
does not contain all the available
information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking Zoton FasTabs
against the benefits this medicine is
expected to have.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT ZOTON FASTABS
IS USED FOR
PEPTIC ULCERS
Zoton FasTabs is used to treat peptic
ulcers in adults. Depending on the
position of the ulcer it is either a
gastric or duodenal ulcer. A gastric
ulcer occurs in the stomach. A
duodenal ulcer occurs in the
duodenum, which is the tube leading
out of the stomach.
Too much acid being made in the
stomach can cause these ulcers.
Zoton FasTabs is also used to help
stop duodenal ulcers from coming
back.
REFLUX OESOPHAGITIS
Zoton FasTabs is used to treat the
symptoms of reflux oesophagitis or
reflux disease in adults and in
children from 6 to 17 years of age.
This can be caused by backflow
(reflux) of food and acid from the
stomach into the food pipe or gullet,
also known as the oesophagus.
Reflux can cause a burning sensation
in the chest rising up to the throat,
also known as heartburn.
HEARTBURN AND STOMACH PAIN
ASSOCIATED WITH REFLUX OR PEPTIC
ULCER.
Zoton FasTabs is used for the short-
term treatment of heartburn and
peptic ulcer symptoms in adults.
PEPTIC ULCERS ASSOCIATED WITH
HELICOBACTER PYLORI INFECTION
Most people who have a peptic ulcer
also have bacteria called
Helicobacter pylori in their stomach.
Zoton FasTabs can be taken in
conjunction with certain antibiotics
to help eradicate Helicobacter pylori
and let your peptic ulcer heal.
However, it is possible that the
antibiotics may not always get rid of
Helicobacter pylori.
_HOW ZOTON FASTABS WORKS_
Zoton FasTabs contains l
Read the complete document
Summary of Product characteristics
Version: pfpzotft10516
Supersedes: pfpzotft10815
Page 1 of 14
PRODUCT INFORMATION
ZOTON
®
FASTABS
(LANSOPRAZOLE)
NAME OF THE MEDICINE
Non-proprietary name:
lansoprazole
The structural formula of lansoprazole is shown below:
CAS Registry Number:
CAS No. 103577-45-3.
Chemical name:
2[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl]
sulphinyl]-1H-benzimidazole.
Molecular formula:
C
16
H
14
F
3
N
3
0
2
S
Molecular weight:
MW 369.36
DESCRIPTION
Lansoprazole is a substituted benzimidazole. It is a white to slightly brownish crystalline, acid-
labile powder, slightly soluble in ethanol and almost insoluble in water (0.033 mg/mL), but more
soluble at higher pH. It is a chiral compound with one centre (-SO) and is present as a racemic
mixture. Lansoprazole melts at 165.8
C with decomposition and has a pKa of 8.8.
Zoton FasTabs contain 15 mg or 30 mg of lansoprazole. The gastro-resistant microgranules
contain the excipients; lactose monohydrate, microcrystalline cellulose, heavy magnesium
carbonate, low-substituted hydroxypropylcellulose, hydroxypropyl cellulose, hypromellose,
titanium dioxide, talc, mannitol, methacrylic acid – ethyl acrylate copolymer (1:1) 30 per cent,
Version: pfpzotft10516
Supersedes: pfpzotft10815
Page 2 of 14
polyacrylate dispersion 30 per cent, macrogol 8000, citric acid anhydrous, glyceryl monostearate,
polysorbate 80, triethyl citrate, iron oxide yellow (E172) and iron oxide red (E172). Other
excipients contained in the tablets are crospovidone, magnesium stearate, strawberry flavour and
aspartame.
PHARMACOLOGY
PHARMACODYNAMICS_ _
Lansoprazole reduces gastric acid secretions by inhibiting the H+/K+-ATPase (proton pu
Read the complete document
